Catalog Number

5702053

Brand Name

Henry Schein

Version/Model Number

5702053

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EJB

Product Code Name

HANDLE, INSTRUMENT, DENTAL

Public Device Record Key

a4edaf24-258d-441e-9ff7-40d7d8d5de51

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-